Actively Recruiting
Letermovir Prophylaxis for Cytomegalovirus Infection After Stem Cell Transplant in Children and Adolescents
Led by Children's Oncology Group · Updated on 2026-05-05
105
Participants Needed
29
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether taking letermovir as a preventive treatment can lower the chance of cytomegalovirus (CMV) infection in children and adolescents undergoing stem cell transplants. This phase III trial focuses on patients aged 2 to 18 years who receive allogeneic hematopoietic cell transplants. CMV infection risk increases after transplant due to weakened immune systems from preparative treatments, and letermovir is an antiviral drug that stops CMV from multiplying to potentially prevent or lessen infection severity. Participants receive letermovir once daily, either by mouth or through an intravenous infusion lasting about 60 minutes, starting the day after transplant and continuing for 14 weeks. Blood samples are collected regularly to test for CMV DNA levels: weekly for the first 14 weeks, then every two weeks up to week 24, and at weeks 32, 40, and 52. The study also monitors survival without CMV infection through 24 weeks and tracks other health outcomes such as time to immune recovery, kidney function, and hospital stays. During the study, participants undergo frequent blood tests to detect CMV infection and immune response. Researchers measure clinically significant CMV infections up to 14 weeks post-transplant as the main outcome, with longer-term follow-up to 52 weeks. Other assessments include monitoring adverse events like neutropenia and kidney issues, plus examining viral resistance patterns. The total participation period includes regular visits and testing across about one year to evaluate letermovir's role in preventing CMV infection after transplant.
CONDITIONS
Brief Title
A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 years and under 18 years at enrollment
- Weight of at least 6 kilograms at enrollment
- Planned allogeneic hematopoietic cell transplant (bone marrow, peripheral blood stem cell, or cord blood)
- Positive cytomegalovirus (CMV) immunoglobulin G antibody status
- Performance status score greater than 50 (Lansky for age ≤16 years, Karnofsky for age >16 years)
- Estimated kidney function with glomerular filtration rate above 10 mL/min/1.73 m² and not on dialysis
- Liver function with direct bilirubin ≤ 2 mg/dL and ALT ≤ 10 times upper limit for age
- Ability to have plasma CMV PCR testing within required time frames
- Signed informed consent obtained
- Compliance with all institutional and regulatory requirements for human studies
You will not qualify if you...
- Unable to tolerate oral letermovir formulation
- Allergy or hypersensitivity to letermovir or its components
- History of CMV end organ disease within 6 months before enrollment
- Prior allogeneic hematopoietic cell transplant within 1 year before enrollment
- Planned use of other anti-CMV medications or cellular therapies during study (including high-dose acyclovir, valacyclovir, foscarnet, ganciclovir, valganciclovir, or CMV-directed cytotoxic T lymphocytes)
- Use of contraindicated medications during study period (such as pimozide, ergot alkaloids; and for cyclosporine recipients, bosentan, pitavastatin, simvastatin) unless stopped at least 14 days before Day +1
- Pregnancy or breastfeeding in female participants
- Sexually active females of reproductive potential not agreeing to effective contraception during and 4 weeks after letermovir treatment
- Failure to meet informed consent or regulatory requirements for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 14 weeks
Participants receive letermovir orally or intravenously once daily starting on day +1 post-transplant for 14 weeks. During this time, blood samples are collected weekly for CMV PCR analysis.
Weekly visits for blood sample collection during treatment
Duration - Up to 38 weeks after treatment (weeks 15 to 52 post-transplant)
After treatment, participants continue to have blood samples collected every 2 weeks until week 24, then at weeks 32, 40, and 52 to monitor for cytomegalovirus infection.
Every 2 weeks until week 24, then at weeks 32, 40, and 52
Trial Site Locations
Total: 29 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
3
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
6
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
7
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
8
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
9
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
13
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
15
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
16
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
17
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
18
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Active, Not Recruiting
21
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
23
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
24
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
25
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
26
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
27
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
28
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Not Yet Recruiting
29
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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